Divalproex Sodium

Treats manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy…. ANDA 79163, held by Unichem Labs Ltd. Divalproex Sodium.

As of Nov 14, 2026, ANDA 79163 (Divalproex Sodium), held by Unichem Labs Ltd, was first approved by FDA on Apr 5, 2011, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 5, 2011
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Divalproex sodium is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches 1.1 Mania Divalproex sodium delayed-release tablets are valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 5, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Divalproex SodiumEQ 125MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Rx
Divalproex SodiumEQ 250MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Rx
Divalproex SodiumEQ 500MG VALPROIC ACID · tablet, delayed release;oral	Divalproex Sodium	Rx

All 18 submissions, including labeling and manufacturing supplements


Nov 5, 2026	Supplement 39Labeling · Standard review	Approved	None posted
Nov 5, 2026	Supplement 36Labeling · Standard review	Approved	None posted
Nov 5, 2026	Supplement 34Labeling · Standard review	Approved	None posted
Dec 5, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Dec 5, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Nov 3, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Nov 3, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 9, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Feb 19, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Feb 19, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Feb 19, 2014	Supplement 1Labeling	Approved	None posted
Apr 5, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 79163
Drugs@FDA: Overview at FDA
Company: Unichem Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters